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# 5 Observations in 17-Page Strides Pharma FDA-483
- URL: https://www.fdaweb.com/5-observations-in-17-page-strides-pharma-fda-483/
- Published: 2026-07-28T12:00:00.000Z
- Updated: 2026-09-14T13:43:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161528

FDA has released the 17-page form FDA-483 issued following a 5/12-5/20 inspection at the Strides Pharma Science drug manufacturing facility in Bangalore, Karnataka, India. The five inspection observations were:

- failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to maintain all records associated with a batch of drug product for at least one year after the expiration date;
- failure to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- failure to exercise controls over computerized manufacturing equipment to ensure that only authorized personnel can create and modify recipes, that obsolete or unauthorized recipes cannot be selected for commercial manufacturing, and that accurate data impact is maintained across the facility’s computerized systems; and
- failure to test each component for conformity with all written specifications for purity, strength, and quality.